Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3130](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3130) → EJX — Anchor, Preformed

# EJX · Anchor, Preformed

_Dental · 21 CFR 872.3130 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJX

## Overview

- **Product Code:** EJX
- **Device Name:** Anchor, Preformed
- **Regulation:** [21 CFR 872.3130](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3130)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A preformed anchor is a device made of austenitic alloys or alloys containing 75 percent or greater gold or metals of the platinum group intended to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient's mouth.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K133088](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJX/K133088.md) | ZX-27 | M&M Dental Studio, Inc. | Jan 2, 2015 | SESE |

## Top Applicants

- M&M Dental Studio, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJX](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EJX)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com